Congo-Kinshasa: New Hope With Ebola Drug Trial

By the time Kambale Kombi Vianey arrived at the Ebola Treatment Centre &lpar;ETC&rpar; in Beni in the Democratic Republic of the Congo in late November&comma; he was at death's door&period; In the week since falling ill&comma; he'd initially been misdiagnosed with malaria and typhoid&comma; and then a traditional healer told him he'd been poisoned&period;

The fourth health worker he consulted took one look at him and told him to go straight to the ETC&period;

"I didn't want to go&comma;" says Mr Kambale&comma; 30&comma; a secondary school mathematics teacher&period; "But I had no fight left in me&period;"

He spent the night at the Médecins Sans Frontières &lpar;MSF&rpar;-run transit facility&comma; where patients stay until Ebola is confirmed or ruled out&period; The following afternoon he got back his result&colon; he tested positive for Ebola&period;

"I couldn't breathe&comma;" says Mr Kambale&comma; remembering the moment he was told the news&period; "I thought&colon; 'I've just been handed a death sentence&semi; I'm going to die&period;'"

There is no cure for Ebola and the mortality rate in this outbreak is about 60&percnt;&period; However&comma; there is new cause for hope&period;

Since the start of this current outbreak in August 2018 - the tenth to hit the DRC since Ebola was discovered in 1976 - patients have had access to one of four investigational treatments on a compassionate basis&period; These drugs - mAb 114&comma; Remdesivir&comma; Zmapp and REGN-EB3 - were offered under an ethical framework developed by the World Health Organization known as the Monitored Emergency Use of Unregistered Interventions &lpar;MEURI&rpar; protocol&period; By 1 January&comma; 248 patients had received one of these four drugs&period; While some patients seemed to improve&comma; there was no scientific evaluation of the efficacy and safety of these drugs&period;

So&comma; on 24 November&comma; the DRC's Ministry of Public Health announced the start of a randomized control trial &lpar;RCT&rpar;&period; WHO is coordinating the trial which is led and funded by the DRC's Institut National de Recherche Biomédicale &lpar;INRB&rpar; and the National Institutes of Health &lpar;NIH&rpar;&comma; a part of the US Department of Health and Human Services&period; Other partners are MSF and ALIMA&period;

"This is the first multi-drug trial for Ebola treatments&comma; and the rigorous collection and analysis of data is expected to deliver clarity about which drug works best&comma;" says Dr Janet Diaz&comma; WHO's team lead for clinical management of emerging infectious diseases and&comma; in this current outbreak&comma; the team lead for care of patients with Ebola&period; "This will ultimately save lives in future outbreaks - either in the DRC or in other countries&period;"

For now&comma; mAb 114 and Remdesivir are being evaluated against Zmapp&comma; the control arm&period; REGN-EB3 will be added to the trial in due course&period; Optimal supportive care is also provided to all patients&period;

Mr Kambale was one of the first patients to be admitted to the trial&period;

Fading fast&comma; he was admitted to the ETC by the doctors from ALIMA&comma; the health NGO that runs the facility&period; After the medical staff explained to him the details of the trial&comma; they asked if he would be willing to participate and he was quick to give his consent&period;

"Our objective now is to discover among these treatments which is the most effective&comma;" says Dr Camara Alseny Modet&comma; the ALIMA doctor who was in charge of running the Beni ETC and is now a trial coordinator&period; As of 6 January&comma; 44 patients have been enrolled in the trial at the Beni ETC&period; Patients at other ETCs&comma; for example in Butembo&comma; will soon also have the opportunity to be part of the trial&period;

It is unlikely that the study will reach its target enrolment number of 336 patients during this outbreak&period; So under the protocol&comma; the trial is permitted to cover multiple outbreaks in multiple countries over a period of 5 years&period;

When a patient consents to be part of the trial&comma; the pharmacy team at the Beni ETC selects a sealed envelope sent from INRB in Kinshasa telling them which drug to administer&period; In this way the trial is randomized&period;

While the trial is important&comma; health workers nevertheless remain clear that their top priority in this outbreak is looking after sick patients and ensuring they have the best care possible&period;

Running a clinical trial is a complex business at the best of times&period; But in Beni it is being conducted during an emergency in an active conflict zone where elections are also taking place&period;

"Security is a big challenge&comma;" says Prof Sabue Mulangu&comma; Ebola research coordinator at the INRB&period; "Sometimes we have to stop our work early because security is not good and staff have to respect curfews&period; We really try to minimize this but it's not easy&comma; I can tell you&period;"

Having come through Ebola&comma; and well on his way to recovery&comma; Mr Kambale had only good words for his doctors&comma; praising their dedication in caring for him and their courage&period; As his condition improved&comma; he was moved from intensive care to the convalescence ward&period; After five days there he was given the all-clear and allowed to go home&period;

Now he is back in the ETC - this time helping to care for other sick patients&period;

"People in this community helped me and now it's my turn to give back&comma;" he explains&period; "This is not one person's story&comma; it affects us all&period; Those who don't believe that Ebola exists are mistaken&period;"

He reflects that it's not easy being part of this trial because Ebola is not a disease that anyone would want to catch - but he is also able to strike a note of optimism&period;

"Maybe in this way&comma; I can convince other people in my town that there is a treatment available for Ebola and that they can get better&period; And if they feel ill&comma; the should go straight to the ETC&period;"